Here's to a Happier New Year?

Just as 2011 was drawing to a close—and, by coincidence, on the same day that the fate of Europe's single currency was under discussion at yet another make-or-break summit of Europe's leaders—the Director General of EFPIA made an ostentatious bid to persuade European policymakers to adopt a more ambitious approach to considering the future for healthcare and medicines.

Richard Bergström, still new in his post, lacks nothing in terms of style. He had issued hundreds of printed invitations to the "first annual EFPIA Director General's lecture," in one of Brussels' largest and most prestigious venues. His chosen theme was, "Is society ready for the new science," and his discourse ranged across the opportunities that pharmacogenomics and personalized medicine offered. But his optimism was shot through with warnings of unfulfilled potential, unless a better fit could be engineered between the challenging new developments in medicine and the inertia and lack of imagination that current regulatory systems suffer from.

Much of Bergström's thesis is well known and uncontroversial. Disease patterns are changing, development costs are rising, payers remain increasingly cautious about reimbursing innovations, many diseases remain untreated ... But he departed from the customary narrative with his flat rejection of the widely held view that there is any crisis in discovery. Research output remains good, he said, brandishing recent examples of effective new therapies in fields ranging from hepatitis to melanoma.

The real crisis, in his view, is that the collective efforts of the pharmaceutical industry are not meeting the collective needs of society, because the signalling between the two is deeply imperfect. The organizations that make regulatory or funding decisions on behalf of society are ill-coordinated between one another within countries, and across the international market from country to country, and their approaches to innovation are clumsy and insensitive. In consequence, industry reacts to ill-judged constraints and incentives, and the pathway to the clinical exploitation of new science is obscured or strewn with unnecessary and inappropriate obstacles.

Bergström provided fewer answers than questions. His chief objective, it seems, was to issue a cry of alarm, and to provoke deeper reflection.

What's in Store?

As 2012 opens up before us, what are the chances of a happier new year? There is certainly no lack of activity programmed at a European level in relation to healthcare and the provision of pharmaceuticals. Brussels bristles, it might be said, with plan and projects.

Among the first to emerge—perhaps this month, even as you read this—will be the legislative proposal to update the European Union's rules on pricing and reimbursement procedures: the Transparency Directive. Delayed from 2011 by last-minute haggling among EU officials over how far it is reasonable to oblige national authorities to come clean (and move more quickly) on reaching their decisions, this measure will offer no panacea to the sort of problems that keep Bergström awake at night. It is largely procedural in effect, since it leaves intact the autonomy that each EU member state enjoys over what prices and reimbursement levels it chooses to set for the products on its market.

However, this largely administrative measure will catalyze and focus much wider discussion during the year on some of the fundamental issues of healthcare economics. It might be legitimate, for instance, for national authorities to take a little longer to reach a reimbursement decision if they are going to conduct a fuller assessment of the overall value to the healthcare system of a particular innovative treatment. But that raises questions about what approach they might be using, how valid its methodology, how rigorous its application, how comparable or compatible it may be with methodologies being employed by national authorities in other countries (and, a fortiori in the EU, in other EU member states—that in theory constitute a single market).

Step forward at this point the EU's network on health technology assessment, EUnetHTA, which has been struggling over the last few years to come up with harmonized—or, at any rate, soundly based—approaches to evaluation. The same day that Bergström was stoking the fires of controversy in Brussels, EUnetHTA was holding its annual conference in Gdansk, Poland, to debate European collaboration in policymaking on health technology assessment in national and cross-border healthcare. The industry is cautious about the developments in this area, and at the very moment Bergström was addressing his audience, his federation (along with half a dozen other European health industry federations) released, in Gdansk, a highly skeptical analysis of the process, accompanied by an unambiguous demand for industry to be admitted to the magic circle that is developing and applying health technology assessment. 2012 will see battle joined across a broad front in this fight for influence over the way that decisions vital to the industry are made, and on what basis.